Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment

August 24, 2026 updated by: National Medical Research Center for Therapy and Preventive Medicine
The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to reveal the specific biomarkers by antibody microarrays.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

One hundred twenty patients with atrial fibrillation will participate in the study.

They will be divided into three groups.

  1. Patients with AF recurrence after the first procedure but with isolated pulmonary veins at the beginning of the second AF ablation b)patients with AF recurrence after repeat PV ablation.
  2. Patients with PV-associated atrial fibrillation. The group will be included patients with freedom of atrial fibrillation after PV isolation (first or repeat procedure).
  3. Healthy volunteers

Groups would be formed from patients who previously underwent atrial fibrillation ablations and whose blood samples have been taken and placed in a biobank before interventional treatment. The first step will include proteomic serum profiling using antibody microarrays in ten subjects will be split into 3 groups. The second step will include validation of selected protein biomarkers, in the total cohort (N=120).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 101990
        • National Research Center for Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients 18-85 years old with s paroxismal or persistant atrial fibrillation and prior interventional treatment

Description

Inclusion Criteria:

• Patient with paroxysmal/persistent atrial fibrillation who underwent interventional treatment

Exclusion Criteria:

  • permanent AF
  • contraindications to oral anticoagulation or heparin
  • chronic kidney disease requiring dialysis
  • untreated hypo- or hyperthyroidism
  • breast feeding
  • pregnancy
  • chronic kidney disease requiring dialysis
  • decompensated heart failure
  • stroke within the last 3 months
  • myocardial infarction within the last 3 months
  • Percutaneous coronary intervention or Coronary Artery Bypass Grafting within the last 3 months
  • active myocarditis
  • artificial valve replacement surgery
  • severe mitral or aortic stenosis
  • coronary artery disease requiring revascularization
  • heart transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy volunteers
Diagnostic test: Proteomic analysis by antibody microarrays
Proteomic analysis by antibody microarrays can be used to identify novel biomarkers and to investigate various signaling pathways including protein phosphorylation and protein-protein interactions. Microchips are manufactured as a matrix of a number of immobilized antibodies covalently bound to the glass, membrane, or gel surfaces. Microchips are used for serum proteomic studies in patients with cardiovascular diseases and cancer
PV associated atrial fibrillation
Diagnostic test: Proteomic analysis by antibody microarrays
Proteomic analysis by antibody microarrays can be used to identify novel biomarkers and to investigate various signaling pathways including protein phosphorylation and protein-protein interactions. Microchips are manufactured as a matrix of a number of immobilized antibodies covalently bound to the glass, membrane, or gel surfaces. Microchips are used for serum proteomic studies in patients with cardiovascular diseases and cancer
non-PV associated arrhythmic focuses
Diagnostic test: Proteomic analysis by antibody microarrays
Proteomic analysis by antibody microarrays can be used to identify novel biomarkers and to investigate various signaling pathways including protein phosphorylation and protein-protein interactions. Microchips are manufactured as a matrix of a number of immobilized antibodies covalently bound to the glass, membrane, or gel surfaces. Microchips are used for serum proteomic studies in patients with cardiovascular diseases and cancer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
proteins after validation
Time Frame: 1 year
number of protein which will be specific for non-PV associated arrhythmic focuses group after validation
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
proteins after screening
Time Frame: 1 year
number of protein which will be specific for non-PV associated arrhythmic focuses group after screening
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Medical Research Center for Therapy and Preventive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 121122200154-7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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